nctnumber
stringlengths 11
11
| Sex
stringclasses 3
values | Age
stringclasses 6
values | Conditions
stringlengths 3
2.83k
| Interventions
stringlengths 9
1.49k
⌀ | Primary Outcome Measures
stringlengths 9
24.1k
⌀ | Brief Summary
stringlengths 32
4.94k
|
|---|---|---|---|---|---|---|
NCT02333175 | ALL | CHILD, ADULT, OLDER_ADULT | Parkinson's Disease|Late Stage Parkinson's Disease | OTHER: Specialist review | UPDRS-ADL part, Disability measure, 6 months | The aim of this project is to evaluate the needs and provision of care for patients in the late stages of Parkinsonism and their carers in several European countries, to compare the effectiveness of different health and social care systems, and to lay the foundation for improved outcomes in this population. The investigators will undertake an in-depth assessment of patients and their care arrangements in a population recruited through networks in six European countries. The systems and procedures that are used in the provision of care will be reviewed through a systematic literature review, interviews and assessments of patients, carers and health care providers, and through a trial comparing assessment by a specialist with management suggestions, guidance and access to telephone advice to that of usual care. Through interviews, questionnaire assessment and review of current health-care and social care arrangement, the investigators will assess the needs, provision of care and use of health-care resources, and their impact on patient and carer outcomes in different countries. National and regional databases will also be interrogated to identify current practice and use of healthcare resources and drug usage. A systematic literature review of the evidence for effective management strategies, analysis of the study data, and evaluation of change in outcomes following specialist review will provide the basis for recommendations in the management of late stage Parkinsonism. The investigators will also evaluate potentially useful outcome measures for use in this patient group. In addition to charting the needs and current care provision for late stage Parkinsonism in different European countries, its cost and effectiveness, and an analysis of health-care and social care predictors of improved outcome, the project will produce a platform for the assessment of patients with late stage Parkinsonism, their current treatment and care provision, as well as guidelines on the management of this late disease phase. |
NCT00076453 | ALL | ADULT, OLDER_ADULT | Osteoarthritis | DEVICE: Lateral wedge orthotic shoe inserts|DEVICE: Standard orthotic shoe inserts | Pain reduction, Years 2 and 3 | Osteoarthritis is a degenerative joint disease and is the most common form of arthritis. This study will evaluate the effectiveness of customized shoe inserts in controlling and relieving the pain of knee osteoarthritis. |
NCT00719186 | FEMALE | ADULT | Pregnancy|Polycystic Ovary Syndrome | DRUG: Clomiphene citrate|DRUG: Letrozole | Live Birth, The primary outcome measure is the occurrence of a live birth during the study period. Safety measures will be the number and type of reported adverse events in subjects and offspring., as few as 5 months, up to 16 months | The primary research hypothesis is that ovulation induction with an aromatase inhibitor (letrozole) is more likely to result in live birth than ovulation induction with a selective estrogen receptor modulator (clomiphene citrate) in infertile women with PCOS. A safety hypothesis will also be incorporated into the primary research hypothesis in which we hypothesize both treatments are equally safe for mother and child.
Secondary research hypotheses include:
1. Treatment with letrozole is more likely to result in singleton pregnancy compared to treatment with clomiphene citrate. Singleton pregnancy is defined as presence of a single intrauterine gestational sac with a single fetal pole and observable heart motion.
2. Treatment with letrozole will less likely result in a first trimester intrauterine fetal demise than treatment with clomiphene citrate. A first trimester IUFD is defined as a pregnancy that ends before 13 weeks gestation.
3. Treatment with letrozole is more likely to result in ovulation (increased ovulation rate) compared to treatment with clomiphene citrate. Ovulation is defined as a midluteal progesterone level ≥ 3 ng/mL.
4. The shortest time to pregnancy will be with letrozole.
5. Age, body mass index, SHBG, testosterone, LH, Anti-Mullerian Hormone (AMH), and degree of hirsutism and acne will be significant predictors of ovulation and conception regardless of treatment.
6. Improvement in SHBG, testosterone, AMH, and LH levels will be significant predictors of ovulation and conception regardless of treatment.
7. DNA polymorphisms in estrogen action genes will predict response to study drug.
8. Quality of Life will be better on letrozole than clomiphene.
9. Letrozole will be more cost effective at achieving singleton pregnancies than clomiphene. |
NCT02786160 | ALL | CHILD | Obesity | DIETARY_SUPPLEMENT: HMO|DIETARY_SUPPLEMENT: Dextropur | Change from baseline in faecal microbiota profile, Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out | The study is a randomised, placebo-controlled, double-blind, parallel study in obese children. A total of 75 obese children in the age 5 to 10 years, enrolled in a childhood obesity treatment program, will be included. The participating children will be randomised into one of three groups consuming either HMO (two groups) or placebo (one group).
The primary objective of the study is to establish the effects of HMOs on the faecal microbiota in children. Secondary objectives are to evaluate safety of HMO supplementation in children and the effect on gastrointestinal symptoms (tolerance), bowel habits, metabolic profile and body composition in obese children. |
NCT02390882 | MALE | ADULT, OLDER_ADULT | Benign Prostate Hyperplasia | DRUG: Placebo|DRUG: HGP0412 capsule|DRUG: HIP1402 capsule | Total International Prostate Symptom Score, 12 weeks | The main objective of this study is to evaluate efficacy and safety of (Tamsulosin) HGP0412 and HIP1402 in patients with Benign Prostatic Hyperplasia |
NCT00986466 | FEMALE | OLDER_ADULT | Falls Prevention|Prevention of Fall-related Injuries | DIETARY_SUPPLEMENT: exercise and vitamin D supplementation|DIETARY_SUPPLEMENT: exercise and vitamin D supplementation|DIETARY_SUPPLEMENT: exercise and vitamin D supplementation|DIETARY_SUPPLEMENT: exercise and vitamin D supplementation | number of falls, 24 months | The aim of the study is to investigate the effects of exercise and vitamin D supplementation on reducing falls and injuries in community-dwelling, independent-living women aged 70-79 years of age. The investigators will test the following hypothesis:
1. Exercise including strength, balance and mobility training will improve muscle functioning and body balance, and thus reduce falls by 30% compared with non-exercisers.
2. Vitamin D intake will improve muscle functioning and thus prevent falls by 30% compared with placebo.
3. Together vitamin D and exercise have a stronger influence on fall prevention than either used alone.
4. Training improves mobility functions and bone health.
5. Supervised training twice a week with daily home training will improve physical functioning thus resulting in reduced fear of falling.
6. Reduced fear of falling and improved physical functioning help older people to stay physically active, which further improve their quality of life. |
NCT02428595 | FEMALE | ADULT, OLDER_ADULT | Fecal Incontinence | DEVICE: Eclipse™ System | Count of Treatment Responders in the Intent to Treat (ITT) Cohort, Count of patients with \>50% reduction in the average number of FI episodes per week as compared to baseline., 3 months | Multi-center, prospective, within-subject control, open label clinical trial to evaluate the durability of the safety and effectiveness of the Eclipse™ System after 3 and 12 months of use. |
NCT01164085 | ALL | ADULT, OLDER_ADULT | Inflammation | DRUG: Intravitreal Ketorolac | Safety, Baseline and 90 day electroretinogram and goldmann visual fields will be compared to assess for retinal toxicity., 90 days | Intraocular delivery of ketorolac will be an effective means to treat inflammation and macular edema and prevent structural complications and vision loss in patients with uveitis who are unable to tolerate corticosteroids due to their side effects. |
NCT02905383 | ALL | OLDER_ADULT | Chest Pain|Pneumonia|Transient Ischemic Attack|Stroke|Functional Failure | OTHER: Exercise | Changes in physical function, Changes in physical function will be measured with The Short Physical Performance Battery (SPPB). This test evaluates balance, mobility and muscle strength by examining an individual's ability to stand with feet together side-by side, semitandem and tandem positions, time to walk 8ft and time to rise from a chair and return to the seated position five times. Each of the three tests is scored, based on performance between 0 and 4, leaving a maximum score of 12 for those individuals performing at the highest levels., Baseline, 4 months and 8 months | The aim of this study is to investigate the effect of a multi-component exercise program on physical function, physical activity and health-related quality of life (HRQOL) in older people recently discharged from hospital. The intervention consists of 32 group-based exercise sessions, performed twice a week. In addition the participants in the intervention group will be encouraged to perform an exercise program on their own, at least once weekly. The participants in the control group will be encouraged to exercise on their own, according to the World Health Organization (WHO) recommendations on physical activity for adults aged 65 and above. |
NCT03215602 | ALL | ADULT, OLDER_ADULT | Knee Osteoarthritis | OTHER: NEMEX and education + strength training|OTHER: NEMEX and education | Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Activities of daily living (ADL), KOOS is a validated and extensively used self-reported outcome measure for people with knee OA. KOOS consists of five subscales, of which the subscale KOOS-ADL will be the primary outcome for this study. KOOS-ADL consists of 17 questions, which are answered on a 4-point likert scale (0=no problems, 4=extreme problems). KOOS-ADL has demonstrated a test-retest reliability (ICC) of 0.84-0.94 as well as demonstrating responsiveness to change following physical therapy in knee osteoarthritis., Primary endpoint: Change from baseline to 12 weeks. Secondary endpoints: 6 weeks & 12 months. | Osteoarthritis (OA) of the knee is a chronic musculoskeletal disease, and a major cause of pain and disability worldwide. Exercise has previously demonstrated good effect in alleviating OA symptoms. However, optimal exercise modes in OA are currently unknown.
This study seeks to evaluate the effects of supplementary focused, knee extensor strength training in addition to neuromuscular exercise (NEMEX) and education in people with OA of the knee as performed in Good Life with osteoArthritis in Denmark (GLA:D ᵀᴹ).
Through a randomized design, study participants will either be allocated to 12 weeks (twice weekly) of NEMEX and education or 12 weeks (twice weekly) of NEMEX and education and focused, knee extensor strength training.
The primary outcome measurement for this study is the Knee injury and Osteoarthritis Outcome Score, subscale Activities of Daily Living (KOOS-ADL), which is a self-reported questionnaire on daily life activities. Other outcomes include parameters of maximal muscle strength and muscle power, muscle imaging, physical function, pain and self-reported health status. |
NCT00910442 | ALL | ADULT, OLDER_ADULT | HIV Infection | DIETARY_SUPPLEMENT: Glutathione precursors | Plasma glutathione, 7 days | The aim of this study is to investigate the responses of the serum amyloid A (SAA) pathway to dietary supplements of glutamine (Gln) and cysteine (Cys) together with methionine (Met)-overloading in HIV+ patients comparatively to healthy controls. |
NCT00666757 | ALL | ADULT, OLDER_ADULT | Depression | DRUG: duloxetine|DRUG: fluoxetine|DRUG: citalopram|DRUG: paroxetine|DRUG: sertraline | Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint], Visitwise probability of participants per treatment meeting remission criteria (QIDS-SR total score \[TS\]\</=5 at week 12 endpoint) were estimated using a pseudolikelihood-based mixed-models repeated measures analysis for a categorical outcome, model included fixed, categorical effects of treatment group (duloxetine vs. SSRIs), visit, treatment group-by-visit \& continuous, fixed covariate of baseline QIDS-SR TS, and random effect of participant. Primary analysis contrasted remission probability at week 12 endpoint between treatment groups., 12 weeks | The purpose of this study is to compare duloxetine with other antidepressants in the treatment of severe depression. |
NCT02289027 | ALL | ADULT, OLDER_ADULT | Ebola Vaccines | BIOLOGICAL: cAd3-EBOZ vaccine|BIOLOGICAL: Placebo (for cAd3-EBOZ vaccine) | Solicited local and systemic reactogenicity signs and symptoms, Solicited local signs and symptoms include: pain at injection site; erythema at injection site; swelling at injection site. They will be assessed according to a preestablished scale (grade 1 to 3).
Solicited systemic signs and symptoms include: fever; tachycardia; bradycardia; systolic hypertension; distolic hypertension; systolic hypotension. They will be assessed according to a preestablished scale (grade 1 to 3)., Daily for 7 days following the vaccination|Unsolicited adverse events of all severities, Unsolicited adverse events will be assessed according to a severity grading scale (grade 1 to 3)., Through 28 days after the vaccination|Change from baseline for safety laboratory measures, Safety laboratory measures include: hemoglobin; white blood cells count; neutrophil count; lymphocyte count; platelets; total bilirubin; alanine aminotransferase (ALT); aspartate aminotransferase (AST); alkaline phosphatase; creatinine; urea; sodium; potassium; partial thromboplastin time (aPTT). They will be assessed according to a severity grading scale (grade 1 to 3)., Through 6 months after the vaccination|Occurrence of serious adverse events and suspected unexpected serious adverse reactions, SAE are defined as AE that result in any of the following outcomes, whether or not considered related to the study intervention:
* Death
* Life-threatening event
* Persistent or significant disability or incapacity
* Hospitalisation
* An important medical event (that may not cause death, be life threatening, or require hospitalisation) that may, based upon appropriate medical judgment, jeopardise the volunteer and/or require medical or surgical intervention to prevent one of the outcomes listed above.
* Congenital anomaly or birth defect.
A SUSAR is a suspected unexpected serious adverse reaction thought to be possibly, probably or definitely related to an IMP. No category of SAE has been defined as 'expected'., Through 6 months after the vaccination | The objective of this trial is to assess in healthy adults the safety and reactogenicity of a new candidate vaccine, cAd3-EBOZ, made of a chimpanzee Adenovirus vector encoding the glycoprotein of Zaire Ebola virus. The secondary objectives will be to assess the immunogenicity of the candidate vaccine and find the most suitable dose for further deployment in epidemic areas in Africa. The 120 planned study subjects will be composed of possibly exposed volunteers owning to organisations such as "Médecins sans frontières" and susceptible to be deployed in the outbreak zone (named as "possibly exposed volunteers"). The other volunteers will be adults with no planned travels to the epidemic zone (named as "not exposed volunteers"). The first group will be randomly allocated to two different groups (low dose = single injection of 2.5x10e10 viral particles (vp), high dose = single injection of 5x10e10 vp). The second group will be randomly allocated to three different groups (low dose = single injection of 2.5x10e10 viral particles (vp), high dose = single injection of 5x10e10 vp or placebo = single injection of vaccine diluent). The design will be double-blind. Follow-up visits will take place at Day 1, 7, 14, 28, 90 and 180. |
NCT01530724 | MALE | ADULT, OLDER_ADULT | Obesity | OTHER: Weight-loss diet strategy (+) exercise (PA)|OTHER: weight loss (-) exercise (PA) | body fat composition, changes in body fat (MRI), 0, 6,18 months|obesity, changes in weight, 0, 6, 18 months|abdominal obesity, changes in waist circumference, 0, 6, 18 months | The investigators hypothesize that differential dynamics in fat depots in response to two opposing dietary strategies mediate the beneficial metabolic effects during weight loss and regain phases. |
NCT00691938 | ALL | ADULT, OLDER_ADULT | Leukemia, Myeloid, Acute|Myelodysplastic Syndromes | DRUG: LBH589|DRUG: Decitabine | Phase I: Maximum Tolerated Dose (MTD) of LBH589 When Given in Combination With Decitabine, Completion of Phase I enrollment for MTD (approximately 26 months)|Phase II: Overall Rate of Morphologic Complete Remission (CR) + Cytogenetic Complete Remission (CRc) + Morphologic Complete Remission With Incomplete Blood Count Recovery (CRi), * Morphologic complete remission (CR). A CR designation requires that the patient achieve the morphologic leukemia-free state with less than 5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells. There should be no blasts with Auer rods or persistence of extramedullary disease. Patients must also have an absolute neutrophil count of more than 1,000/μLand platelets of 100,000/μL.
* Cytogenetic complete remission (CRc). A CRc will be defined by the achievement of a CR with reversion to a normal karyotype in a minimum of 20 metaphases analyzed by cytogenetics.
* Morphologic complete remission with incomplete blood count recovery (CRi): Achievement of all of the criteria for CR except for residual neutropenia (\< 1,000/μL) or thrombocytopenia (\< 100,000/μL)., Up to 12 months | This study is designed to evaluate the combination of LBH589 and decitabine in patients age ≥ 60 years with high risk Myelodysplastic Syndrome (IPSS Int-2 or High) or Acute Myeloid Leukemia. |
NCT01079117 | ALL | ADULT, OLDER_ADULT | Opiate Dependent | DRUG: Sevre-Long™|DRUG: Slow release oral morphine|DRUG: Methadone | Proportion of positive urine tests for by-consumption of target substances per subject, The primary efficacy endpoint in this study is the proportion of positive urine tests for by-consumption of target substances per subject.
Target substances are defined as all opioids except the study drug. The proportions are compared between substitution with methadone and SROM treatment in a crossover design., each week during the 22 week cross-over phase | To compare the effectiveness of slow release oral morphine treatment in patients that previously have been treated with methadone |
NCT02330172 | ALL | ADULT, OLDER_ADULT | Neuromuscular Blockade | OTHER: Injection of neostigmine or sugammadex | Laryngoscopic Score, Definitions for evaluation of Laryngoscopycondition.
: Easy = jaw relaxed, no resistance to blade insertion, fair = jaw not fully relaxed, slight resistance to blade insertion, difficult = poor jaw relaxation, active resistance of the patient to laryngoscopy.
Variables Excellent Good Poor, At the beginning of surgery, the surgeon rated the laryngoscopy condition | This study aims to make a comparison of surgical condition and recovery time between rocuronium 0.45 mg/kg and neostigmine group and rocuronium 0.9 mg/kg and sugammadex group. |
NCT02771132 | ALL | CHILD | Sexual Assault and Rape|Violence, Non-accidental | BEHAVIORAL: 12-hr "IMPower" empowerment self defense course|BEHAVIORAL: 12-hr Source of Strength for boys|BEHAVIORAL: Life-skills course | Sexual Assault Incidence (WHO-Violence Against Women Survey), self-reports of sexual assault within past 12 months, compared between control and intervention groups, 12 months | The primary objective of this study is to compare the effectiveness of classroom-based behavioral interventions (12-hour girls program and 12-hour boys program), to a standard-of care intervention, on reducing the incidence of self-reported sexual assault among girls from baseline.
Secondary objectives of this study is to determine the impact of the interventions on related physical and mental health status/outcomes, STI-risk behaviors, self-efficacy, and self-esteem. |
NCT04591379 | ALL | ADULT, OLDER_ADULT | Colorectal Cancer | DRUG: Influenza Vaccines | Safety - Adverse reactions are classified according to CTCAE version 4.0, To investigate if intratumoral influenza vaccine is a safe treatment modality for tumor down staging prior to intended curative surgery in patients undergoing treatment for colorectal cancer.
Adverse events / reactions are recorded from day of treatment (Day 0) until the surgery, as it will be difficult to differ between adverse events/reactions to the experimental treatment or surgery. All adverse events / reactions should be described in medical terminology in the patient's file and recorded in case report forms (CRF). The following information must be recorded: start date/date when observed, severity, any initiated treatment, assessment of the AE if it meets the criteria for SAE, end date, and relationship to study drug. For AEs that meet the criteria for SAE, the outcome must be recorded., Day of surgery (day 7-14 after treatment) | The aim of this explorative phase II clinical trial is to establish the safety and efficacy of intratumoral influenza vaccine in patients with colorectal cancer, as an additive treatment prior to intended curative surgery. |
NCT00272441 | ALL | CHILD, ADULT | Asthma|Lung Diseases | DRUG: inhaled corticosteroids | null | To evaluate current and novel therapies and management strategies for children with asthma. The emphasis is on clinical trials that help identify optimal therapy for children with different asthma phenotypes, genotypes, and ethnic backgrounds and children at different developmental stages. |
NCT02777229 | ALL | ADULT, OLDER_ADULT | HIV-1 Infection | DRUG: Dolutegravir 50 mg|DRUG: Tenofovir disoproxil fumarate 300 mg / lamivudine 300 mg|DRUG: Efavirenz 400 mg | Proportion of patients with Viral Load (VL) <50 cp/mL, Proportion of patients with Viral Load (VL) \<50 cp/mL at week 48 (FDA snapshot algorithm), week 48 | Several reports indicate that treatment failure due to HIV resistance or to adverse event-related discontinuation could compromise the effectiveness of scaling-up antiretroviral treatment (ART), especially when lack of access to viral load is a concern. Combined with other nucleoside reverse transcriptase inhibitor, Dolutegravir (DTG) is a very promising alternative to the current first-line non nucleoside reverse transcriptase inhibitor-based regimens.
Initial evaluations of DTG conducted in high income countries showed excellent efficacy and safety and indicated high genetic barrier thus preserving second line treatment. As a consequence, DTG-based regimens have been recently included in the first-line options in the national guidelines for ART of several high-income countries. However, the clinical trials evaluating DTG-based regimens have been conducted in highly controlled conditions, including baseline resistance testing and regular viral load monitoring. Moreover, these trials included a high proportion of men with rare co-morbidities.
There is need to evaluate how a DTG-based regimen will perform in real-world conditions within resources-constrained settings, where viral load monitoring is limited, and where the majority of HIV patients are women with important family planning consideration and NAMSAL trial is a randomized clinical trial which aims to evaluate efficacy and safety over 48, 96 and 192 weeks of DTG + tenofovir disoproxil fumarate/lamivudine versus Efavirenz (EFV) + tenofovir disoproxil fumarate/lamivudine in 606 ART-naïve HIV-1-infected adults in Cameroon. A set of efficacy and safety endpoints will be compared over 48, 96 and 192 weeks between the two arms including the proportion of patients with viral load \<50 copies/mL and incidence of severe adverse events. |
NCT00678392 | ALL | ADULT, OLDER_ADULT | Kidney Neoplasms | DRUG: Axitinib (AG-013736)|DRUG: Sorafenib | Progression-Free Survival (PFS), PFS was defined as the time in months from start of study treatment to the first documentation of objective tumor progression of disease (PD) or to death due to any cause, whichever occurs first. PD was assessed by response evaluation criteria in solid tumors (RECIST) version 1.0. PD: \>=20 percent (%) increase in the sum of the longest dimensions (LD) of the target lesions taking as a reference the smallest sum of the LD recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. Occurrence of a pleural effusion or ascites was also considered PD if demonstrated by cytological investigation and it was not previously documented. New bone lesions not previously documented were considered PD if confirmed by computed tomography/magnetic resonance imaging or X-ray., From initiation of treatment up to follow-up period (up to 3 years) | The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer after failure of one first line regimen. |
NCT02400463 | ALL | ADULT, OLDER_ADULT | Hemophagocytic Syndrome (HPS) | DRUG: Ruxolitinib | Overall Survival at 2 Months, Number of Patients Alive at 2 Months after the first administration of ruxolitinib., 2 Months | This is a pilot study to determine the efficacy of Ruxolitinib in secondary hemophagocytic syndrome. The primary objective is to assess the efficacy of ruxolitinib 15 mg PO twice daily in patients with HPS. The primary endpoint is overall survival at two months. |
NCT00347386 | ALL | CHILD | Sepsis|Bacterial Infections|Pneumonia | DRUG: Drug: Zinc (zinc sulphate)|DRUG: Placebo | proportion with treatment failures, Within 3 weeks after enrollment | Infections are the important cause of high mortality in young infants in developing countries. Zinc is a crucial micronutrient as it influences various immune mechanisms and modulates host resistance to several pathogens. It has shown benefits as an adjunct therapy in infections like diarrhea and pneumonia in older children Given the predisposition of young infants in developing countries to zinc deficiency and infections, addition of zinc to standard treatment of serious bacterial infections may lead to significant improvements in the outcomes.
Several hypotheses will be examined in this clinical trial. The primary objective is to measure, in a double blind randomized controlled trial, the efficacy of giving 2 RDA (Required Daily Allowance 10 mg) of zinc orally in addition to routine antibiotics, for treatment of possible serious bacterial infection in infants \>= 7 days and up to 4 months of age in reducing the proportion of treatment failures and time to discharge from the hospital. This will evaluate the clinical consequences of the possible immunomodulation by zinc supplementation. This is critical to demonstrate because nearly 80% of infant mortality occurs in first months of life.
Young infants with possible serious bacterial infections fulfilling the inclusion criteria will be enrolled in the study and stratified into 4 groups on basis of weight for age 'z' scores \< -2 z and \>=- 2 z and whether he/she has diarrhea or not. Within each stratum the subjects will be randomized to receive zinc or placebo. Treatment failures will be defined by the need for a change of initial antibiotic therapy. The minimum duration of monitoring will be till clinical recovery (using predetermined criteria). Serum copper, serum ferritin and serum transferrin receptors will be determined at enrollment, 72 hours after enrollment and at discharge from the hospital. Concentrations of CRP and procalcitonin will be measured at baseline, 72 hours after enrolment and at clinical recovery.
Documentation of efficacy of addition of zinc to standard therapy may provide a simple and low-cost strategy to improve survival in serious infections in young infants. This is likely to have a significant impact on infant morbidity and mortality. It will be good example of using a simple immunomodulator beneficially in improving child health. |
NCT00078403 | ALL | ADULT, OLDER_ADULT | HIV Infections|Hepatitis C|Liver Disease | DRUG: Peginterferon alfa-2a|DRUG: Ribavirin | Time-scaled Change in Metavir Liver Fibrosis Score (SCMFS), SCMFS is the difference between the Metavir fibrosis scores of the study exit and study entry liver biopsies where the difference is scaled to one year. The SCMFS assesses the annualized change in the severity of liver fibrosis on a continuous scale from -4.0 Metavir units per year (reduced fibrosis over time, a positive study outcome) to +4.0 Metavir units per year (increased fibrosis over time)., Baseline and at week 72 or premature discontinuation | Infection with both HIV and hepatitis C virus (HCV) may result in serious and sometimes fatal liver disease. The purpose of this study was to test the effectiveness of long-term pegylated interferon alfa-2a (PEG-IFN) and ribavirin treatment in slowing liver disease progression in people infected with both HIV and HCV. |
NCT00803959 | FEMALE | ADULT, OLDER_ADULT | Urinary Incontinence | OTHER: Office evaluation|OTHER: UDS | Self-reported Urinary Incontinence, Irritative and Obstructive Symptoms: Reduction of 70%+ in the Urogenital Distress Inventory From Baseline to 12 Mos and "Very Much" or "Much" Better on the Patient Global Impression of Improvement Measure at 12 Mos., Treatment success is defined as a reduction in the Urogenital Distress Inventory score from baseline to 12 months of 70% or more and a Patient Global Impression of Improvement response of "very much better" or "much better" at 12 months., 12 Months | Although no reliable and specific figures are available for the total expenditure on UDS, UDS is commonly performed for patients with urinary incontinence (UI) regardless of gender and age. UDS is typically performed prior to incontinence surgery. Urodynamic studies are expensive, time-consuming, and uncomfortable diagnostic investigations. The 3rd ICI reported insufficient evidence with which to answer the following key research questions related to UDS: 1) Do physicians alter clinical decision-making based on results of UDS?, and 2) Do alterations in clinical decisions made in response to UDS results improve the clinical outcomes? |
NCT02043509 | FEMALE | CHILD, ADULT, OLDER_ADULT | Pregnancy|Smoking | BEHAVIORAL: MiQuit | Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Biochemically Validated at Late Pregnancy., The primary smoking outcome measure will be the number of participants reporting continuous abstinence from smoking from 4 weeks after randomisation until follow up at the end of pregnancy (approximately 36 weeks gestation), validated by exhaled CO and/or saliva cotinine estimation at approximately 36 weeks gestation., 36 weeks gestation | The overall aim of the study is to estimate the likely impact of the MiQuit text message based smoking cessation service for pregnant smokers and to establish robust estimates for the key factors which would be required in order to design a larger definitive trial of this intervention(MiQuit).
These key factors include: the range of recruitment rates in different centres; quit rates amongst participants; feasibility of assessing smoking status of participants in later pregnancy; and the likely effect of MiQuit when women are offered this in National Health Service (NHS) settings. |
NCT03332563 | ALL | CHILD | Chronic Pain | BEHAVIORAL: Cognitive-behavioral intervention for chronic pain | Change in activity limitations, The 9-item Child Activity Limitations Interview (CALI-9) will be completed on the online diary to rate perceived difficulty in completing 9 daily activities due to pain, Baseline to 3 month followup | Approximately 5-8% of children report severe chronic pain and disability. Although evidence supports pain-self management as effective for reducing pain and disability, data show that most youth do not have access to this intervention. The investigative team's prior studies demonstrate that technology-delivered pain self-management (WebMAP program) can reduce barriers to care, is feasible, acceptable, and effective in reducing pain-related disability and improving anxiety and depression in youth with chronic pain. In this trial, the investigators propose an implementation project to address critical challenges in nationwide dissemination of the WebMAP pain self-management program. Using a hybrid effectiveness-implementation trial design, 8 clinics from across the U.S. will participate in a pragmatic randomized controlled trial with a stepped wedge design to sequentially implement WebMAP in the clinics following randomized usual care periods. Data will be collected from clinic records, web and app administrative tracking, and provider surveys to gather information on adoption and implementation following the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) public health impact framework. Individual patient-level pain outcomes will be collected from 140 patients to evaluate intervention effectiveness. The expected outcome of the project is to yield a strategic approach for a nationwide technology-delivered pain self-management intervention for youth with chronic pain that can be readily sustained in clinical settings. |
NCT01892098 | FEMALE | CHILD | Bone|Growth|Osteoporosis | DIETARY_SUPPLEMENT: Zinc Sulfate|DIETARY_SUPPLEMENT: Placebo | Serum Zinc, Serum Zinc will be measured at the Baseline and 4 week time point to determine effects of placebo vs. supplement., 4 weeks|Plasma IGF-1 and IGFBP-3, Plasma IGF-1 and IGFBP-3 will be measured at Baseline and 4-weeks and analyzed using ELISA to determine changes., 4 weeks|procollagen type 1 amino-terminal propeptide (P1NP), Bone turnover marker procollagen type 1 amino-terminal propeptide,, 4 weeks | The purpose of the study is to determine the effects of zinc supplementation on bone growth over four weeks. Participants will agree to attend two visits to our laboratory and at each will complete blood and urine samples, questionnaires related to diet and physical activity and will receive a bone scan at the first appointment. |
NCT02651402 | ALL | CHILD, ADULT, OLDER_ADULT | Anxiety Disorders | BEHAVIORAL: FRIENDS for Life|BEHAVIORAL: Adapted FRIENDS|BEHAVIORAL: Train-the-Trainer|BEHAVIORAL: Train-the-Trainer Plus | Change in Manifest Anxiety Scale for Children (MASC) from Baseline to Post Intervention completed by parents and children, Effectiveness between treatment groups will be assessed by comparing the change in diagnostic status from pre to post intervention. Diagnostic status will be assessed using the Anxiety Disorders Interview Schedule for Children (ADIS-P) which includes a semi-structured interview used to determine diagnostic status and outcome. Clinical judgement is used to generate a Clinician Severity Rating (CSR). A CSR \>4 is a clinical diagnosis of an anxiety disorder, CSR=3 patient at risk for developing a disorder., Up to 12 weeks | Unresolved psychological problems, such as anxiety, affect a significant number of our students and interfere with their ability to attend, actively participate, and prosper in school. This project will expand the capacity of selected mental health agencies to provide services in the participating schools through school therapeutic services (STS). The project will provide enhanced training in evidence-based behavioral health interventions to school-based mental health providers. The services will be implemented by STS Bachelor's or Master's level therapists supervised by their mental health agency supervisors (Internal Support), who are in turn supported by the research team (Train-the-Trainer) or external consultants (Train the Trainer+). |
NCT01776424 | ALL | ADULT, OLDER_ADULT | Prevention & Control | DRUG: Rivaroxaban (Xarelto, BAY59-7939)|DRUG: Rivaroxaban (Xarelto, BAY59-7939)|DRUG: Aspirin|DRUG: Aspirin placebo|DRUG: Rivaroxaban placebo|DRUG: Pantoprazole|DRUG: Pantoprazole placebo | The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death, Count of participants and time from randomization to the first occurrence of the composite primary efficacy outcome, MI, stroke, or CV death were evaluated. Hazard ratios were calculated and reported as statistical analysis., For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.|The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria, Modified ISTH major bleeding is defined as: i) Fatal bleeding, or ii) Symptomatic bleeding in a critical area or organ, such as intraarticular, intracranial, intramuscular with compartment syndrome, intraocular, intraspinal, liver, pancreas, pericardial, respiratory, retroperitoneal, adrenal gland or kidney; or bleeding into the surgical site requiring reoperation, or iii) Bleeding leading to hospitalization (major bleeding also includes presentation to an acute care facility with discharge on the same day).
Count of participants and time from randomization to the first occurrence of the primary safety outcome major bleeding were evaluated. Hazard ratios were calculated and reported as statistical analysis., For each participant, the first occurrence of modified ISTH major bleeding after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days. | The primary objectives of this study are:
* To determine whether rivaroxaban 2.5 mg twice daily (bid) + aspirin 100 mg once daily (od) compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with coronary artery disease (CAD) or peripheral artery disease (PAD);
* To determine whether rivaroxaban 5 mg bid compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke or cardiovascular death in subjects with CAD or PAD. |
NCT02361112 | ALL | ADULT, OLDER_ADULT | Metastatic Breast Cancer | DRUG: pyrotinib combined with capecitabine | The maximum-tolerated dose (MTD) will be defined as the maximum dose level at which no more than one subject out of three experiences has a dose-limiting toxicity (DLT) upon completing one treatment cycle., DLT was difined as the cetain AEs which were observed during the first cycle (D1-D21）of treatment., 21 days | Pyrotinib is an oral tyrosine kinase inhibitor targeting both EGFR and HER-2 receptors. This study is designed to evaluate the safety and tolerability of Pyrotinib in combination with capecitabine in patients with HER2 positive metastatic breast cancer:
To evaluate the safety and tolerability of pyrotinib, and the maximum tolerated dose (MTD) To determine the dose-limiting toxicity (DLT) To determine the pharmacokinetic profile of Pyrotinib To assess preliminary antitumor activity To determine preliminary regimen dose for phase II study |
NCT02509702 | FEMALE | ADULT | Cervical Cancer | BEHAVIORAL: Connected to Care | Effect of SMS intervention on attendance rate to follow-up screening appointment, The effect measure of the intervention is the 14-month follow-up attendance rate for HPV positive women. The number of women in the intervention group that attend follow-up screening will be compared to the the number of women that attend follow-up screening in the control group., up to 14 months | This study evaluates the effect of the SMS intervention 'Connected2Care' on the attendance rate to cervical cancer screening follow-up appointments. |
NCT02367729 | ALL | CHILD, ADULT | Functional Disorder of Intestine|Nausea Persistent | DEVICE: Neurostimulator|DEVICE: Sham | Pain Frequency-Severity-Duration Scale (PFSD) Score, One-page, 6-item pain measure assessing pain symptoms over the past week. Measures the typical and worst pain intensity, frequency and duration over the past week in units on a scale from 0 to 10 (10 being the worst pain imaginable). Worst pain = primary outcome., Change from Baseline to Week 4 | This study evaluates the effectiveness of a neurostimulator applied to the outer ear for adolescents with functional gastrointestinal disorders. The neurostimulator provides nerve stimulation to a branch of the vagus nerve which is thought to be involved in transmission of pain signals. Half of the study subjects will receive an active nerve stimulator while the other half will receive an inactive one. |
NCT03336411 | ALL | ADULT, OLDER_ADULT | Pre-diabetes|Overweight and Obesity | BEHAVIORAL: mHealth|BEHAVIORAL: Personalized mHealth | Body weight, percent change, the primary outcome will be relative weight change as a percentage of body weight at baseline and 6-months using calibrated scale., 6 months | The aim of this 2-phase, randomized clinical trial will be to examine the effects of two behavioral weight loss interventions on weight loss. This study will be conducted in 200 overweight or obese prediabetic individuals recruited from community-based settings.. Phase 1 will include 6-months of active intervention. Phase 2 will consist of 6-months of maintenance and observation. Measurements will occur at screening, baseline, 3, 6, and 12 months. Participants will be randomized with equal allocation to 2 groups: (1) a standardized behavioral weight loss intervention with a one-size-fits-all regimen that includes counseling about restriction of calories and calories from fat, and physical activity, delivered using mHealth technology, or (2) all of the elements of mHealth, plus personalized dietary recommendations to minimize glycemic response to meals. Participants will be required to attend 6 separate visits over both phases of the study. |
NCT01022905 | ALL | CHILD, ADULT, OLDER_ADULT | HIV Infection|Rheumatic Disease|Cancer|Transplant|Pediatrics | BIOLOGICAL: Adjuvanted influenza A(H1N1) vaccines | Antibody responses (inhibition of hemagglutination), 4-6 weeks after immunization | The objective of this study is to assess vaccine responses to novel adjuvanted influenza A(H1N1) vaccines in patients at high risks of influenza A(H1N1) complications. |
NCT00543673 | ALL | CHILD | Healthy | OTHER: Milk based formula A|OTHER: #2 Standard formula|OTHER: #3 Human Milk|OTHER: Milk based formula C | Mean rank stool consistency (MRSC), Study Day 1 to Visit 3 | To assess the gastrointestinal tolerance of healthy full-term infants fed either experimental formula or a control formula |
NCT01084239 | ALL | ADULT, OLDER_ADULT | Acute Coronary Syndrome|Myocardial Infarction|Unstable Angina Pectoris | RADIATION: Cardiac Computed Tomography | Length of Hospital Stay, Duration of stay in the hospital during the initial visit | The growing availability of cardiac computed tomography (CT)\* in emergency departments (EDs) across the U.S. expands the opportunities for its clinical application, but also heightens the need to define its appropriate use in the evaluation of patients with acute chest pain. To address this need, we performed a randomized diagnostic trial (RDT) to determine whether integrating cardiac CT, along with the information it provides on coronary artery disease (CAD) and left ventricular (LV) function, can improve the efficiency of the management of these patients (i.e. shorten length of hospital stay, increase direct discharge rates from the ED, decreasing healthcare costs and improving cost effectiveness while being safe). |
NCT01869894 | ALL | ADULT, OLDER_ADULT | Malignant Biliary Obstruction | PROCEDURE: metallic biliary stent insertion (double bare - S&G Biotech.)|PROCEDURE: metallic biliary stent insertion (single bare - S&G Biotech.)|PROCEDURE: metallic biliary stent insertion (single bare - Taewoong Medical.) | Median patency duration, Primary end point : A. Median patency duration, Approximately 6 months later since the date of stent insertion | Our study is the prospective randomized study for efficacy of uncovered double bare metallic stent compared to uncovered single bare metallic stent in malignant biliary obstruction |
NCT01428596 | ALL | ADULT | HIV Infections | BIOLOGICAL: HIVAX|BIOLOGICAL: saline solution|BIOLOGICAL: HIVAX | • To evaluate the safety of a replication-defective HIV-1 vaccine (HIVAX™) in HIV-1 infected subjects on highly active antiretroviral therapy., Frequency and severity of adverse events, laboratory abnormalities, and local and systemic reactogenicity signs and symptoms following vaccinations., 48 weeks|• To evaluate the potential immunogenicity of a replication-defective HIV-1 vaccine (HIVAX™) as determined by IFN-γ and IL-2 ELISPOT to pooled gag and env HIV peptides., Magnitude of IFN-γ \& IL-2 producing CD4+ and CD8+ T cells to pooled gag and env HIV peptides at 4 weeks post vaccinations., 48 weeks | This study is to test a therapeutic HIV-1 vaccine (HIVAX™) in HIV-1 infected subjects. The safety and immune responses will be studied in vaccine recipients. The anti-viral effect of HIVAX vaccine will be monitored during a 12-week treatment interruption phase. |
NCT00108004 | ALL | ADULT, OLDER_ADULT | Type 1 Diabetes Mellitus|Type 2 Diabetes Mellitus | DRUG: pramlintide acetate | To investigate the clinical utility and safety of pramlintide in subjects with type 1 and type 2 diabetes mellitus, To investigate the clinical utility (change in HbA1c, seven-point glucose profile, body weight, and insulin use) and safety of pramlintide in subjects with type 1 and type 2 diabetes mellitus who have not achieved glycemic targets with insulin therapy., 6 months|Understand management issues in subjects with type 1 and type 2 diabetes mellitus, To collect data regarding the selection of subjects for pramlintide administration by healthcare professionals and to further understand management issues in subjects with type 1 and type 2 diabetes mellitus who have not achieved glycemic targets with insulin therapy, 6 months | This open-label, multicenter study is designed to investigate the clinical utility and safety of pramlintide treatment in subjects with type 1 and type 2 diabetes who are failing to achieve the desired level of glycemic control using insulin therapy. |
NCT02399657 | ALL | ADULT, OLDER_ADULT | Diabetes Mellitus|Macular Edema|Retinal Exudates and Deposits | DRUG: Intravitreal dexamethasone 0.7mg implant | The ratio of eyes showing reduced hard exudates in macula (1500 micrometer from foveal center), after 12 months | A Single Arm, Single Dose Study to Evaluate the Effect of intravitreal dexamethasone implant (Ozurdex®) on hard exudates of diabetic macular edema. |
NCT00120367 | ALL | ADULT, OLDER_ADULT | Leukoencephalopathy, Progressive Multifocal|HIV Infections | DRUG: Enfuvirtide|DRUG: Tenofovir-Emtricitabine | Estimation by the method of Kaplan-Meier of the rate of survival at M12 | Progressive multifocal leucoencephalopathy (PML) is a rare infectious disease of the brain, provoked by the JC virus. It usually occurs in subjects with impaired immune system as during HIV infection. To date, there is no specific antiviral treatment susceptible to cure PML. But it was shown in the setting of HIV-related PML, that combination antiretroviral therapy allows a restoration of the immune system and then might stop the progression of PML.
The objective of this study is to appreciate the supplementary efficiency brought by an association of more powerful antiretroviral molecules including enfuvirtide on the evolution of PML. This research program will involve 30 patients in several centres in France. All the patients who will participate will receive enfuvirtide during 6 months in association with a combination of two or more potent antiretroviral drugs. The total duration of follow-up for a patient will be of 1 year. |
NCT02454686 | ALL | ADULT, OLDER_ADULT | Liver Neoplasms | null | Accuracy of Fibroscan in predicting complication after hepatectomy, Calculation of the accuracy of the liver stiffness and steatosis measured with the Fibroscan in predicting complications after hepatectomy. The values of the stiffness and steatosis will be correlated with the number of complications, 90 days | Most of the postoperative complications that may occur after hepatectomy are related to the underlying liver background, and the common preoperative tests do not completely predict such complications. Transient elastography by Fibroscan is used to calculate the stiffness and the steatosis of the liver, and it may be also used to predict postoperative complications after hepatectomy |
NCT03650777 | ALL | ADULT, OLDER_ADULT | Educational Problems|Medication Adherence | OTHER: Warfarin Telehealth Education | Knowledge Retention of Warfarin Education post video watching, Difference in pre warfarin education video and post video test for warfarin education in patients receiving warfarin education via iPad, pre and post video test(20 minutes)|Long Term Knowledge Retention of warfarin education post video watching, Difference in pre video test and follow up retention test for warfarin education in patients receiving warfarin education via iPad, initial and follow up visit (max 30 days) | The objective of this study is to evaluate the effectiveness of telehealth warfarin education in a charity outpatient clinic. The purpose is to increase patient knowledge with regard to their warfarin therapy and to measure knowledge retention |
NCT00940394 | ALL | ADULT | Schizophrenia | BEHAVIORAL: mutual support group|BEHAVIORAL: psychoeducation group|OTHER: Standard care | length of re-hospitalizations, at recruitment, six-month, 18-month and 36-month post-intervention | The mutual support group intervention would significantly improve the families' burden of care, functioning and social support, reduce the patients' severity of symptoms and re-hospitalizations, and reduce the demands for utilization of family services, when compared with the standard care group. |
NCT01130870 | ALL | ADULT, OLDER_ADULT | Fecal Incontinence | DEVICE: Sensory Threshold|DEVICE: 75% of sensory threshold - Amplitude|DEVICE: 50% of sensory threshold - Amplitude | Number of incontinence episodes Assess number of incontinence episodes., Assess number of incontinence episodes, by means of bowel habit diary. Four week bowel habit diary will be evaluated three times during the twelve-week protocol perioed., Will be assessed every four weeks during a twelve-week period | The purpose of this study is to determine if subsensory stimulation (amplitude) will maintain same continence in patients treated with Sacral Nerve Stimulation (SNS) for faecal incontinence as stimulation with amplitude at sensory threshold. |
NCT05271045 | ALL | ADULT, OLDER_ADULT | Diabetes | DIETARY_SUPPLEMENT: fortified canola oil with vitamins A and D and γ-oryzanol|DIETARY_SUPPLEMENT: Active comparator|DIETARY_SUPPLEMENT: Placebo | serum glucose (mg/dL), Fasting serum glucose level, 8 weeks|serum HbA1c (mg/dL), Fasting serum HbA1c level, 8 weeks | The aim of this study is to evaluate the efficacy of daily intake of fortified canola oil with vitamins A and D and γ-oryzanol on anthropometric, inflammatory, immunity, appetite and metabolic indicators of adults with type 2 diabetes compared to canola and sunflower oil without γoryzanol. |
NCT01704365 | FEMALE | ADULT | Respiratory Syncytial Virus (RSV) | BIOLOGICAL: Low dose RSV-F Vaccine with Adjuvant|BIOLOGICAL: Low dose RSV-F Vaccine without Adjuvant|BIOLOGICAL: High dose RSV-F Vaccine with Adjuvant|BIOLOGICAL: High dose RSV-F Vaccine without Adjuvant|BIOLOGICAL: Low dose RSV-F Vaccine with Adjuvant [Bedside Mixing]|BIOLOGICAL: Placebo | Immunogenicity as assessed by serum IgG antibody titers specific for the F-Protein antigen across treatment groups, Immunogenicity will be measured using derived / calculated endpoints based on:
* Geometric mean titer (GMT)
* Geometric mean ratio (GMR)
* Seroconversion rate (SCR)
* Seroresponse rate (SRR), Day 0 to Day 112|Assessment of the safety, Number (and percentage) of subjects with solicited local and systemic Adverse Events over the seven days post-injections; all adverse events, solicited and unsolicited over 56 days post-first injection.
Significant New Medical Conditions, Medically Attended Events and Serious Adverse Events will be collected for six months, Day 0 to Day 182 | The purpose of this study is to evaluate the immunogenicty and safety of an RSV-F protein nanoparticle vaccine, with out without aluminum, in healthy women of child-bearing potential. |
NCT04537520 | ALL | ADULT, OLDER_ADULT | Diabetes|Diabetic Foot Ulcer | DEVICE: Kerecis Omega3 Wound | Wound area, measuring the surface of the wound with planimetry software, Week 0|Wound area, measuring the surface of the wound with planimetry software, Week 16 | The KereFish study is a randomized controlled study to study the efficacy of Kerecis Omega3 Wound on deep diabetic ulcers. This study is probably the first in his field: in this one, the Kerecis Omega3 Wound dies are used on the types of wounds for which they are ultimately intended. This study aims to document the cost benefits of earlier closure of severe diabetic wounds, or the change of the deep and chronic wound into a smaller and shallower ulcer, and to radically alter its prognosis. The study, carried out in France, uses the pre-existing home nursing system with the transmission of photographs to the reference centre. The study was largely designed to ensure transparency of the financial calculations involved. |
NCT00006327 | ALL | ADULT | HIV Infections|HIV Seronegativity | BIOLOGICAL: MN rgp120/HIV-1 and A244 rgp120/HIV-1 | null | The purpose of this study is to determine if the vaccine, AIDSVAX B/E, will protect intravenous drug users from becoming infected with HIV. |
NCT01174550 | ALL | ADULT, OLDER_ADULT | Chest Pain | PROCEDURE: Coronary Angiography|PROCEDURE: Stress Echocardiogram|PROCEDURE: Nuclear Stress Test|PROCEDURE: Exercise Electrocardiogram | Time to Primary Endpoint, Time to primary endpoint as defined as a composite of death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, and unstable angina hospitalization. The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups., 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months | A prospective multicenter imaging study for evaluation of chest pain. Objective is to determine whether an initial non-invasive anatomic imaging strategy with coronary CT angiography (CTA) will improve clinical outcomes in subjects with symptoms concerning for coronary artery disease relative to an initial functional testing strategy (usual care). Study hypothesis: initial anatomic testing strategy will provide information that will result in superior long-term health outcomes as compared to an initial functional testing strategy. |
NCT00611481 | ALL | ADULT, OLDER_ADULT | Parkinson's Disease | BEHAVIORAL: Tai Chi|BEHAVIORAL: Strength training|BEHAVIORAL: Low-Impact Exercise Control | Balance, 3 time points | Patients practicing Tai Chi will exhibit significant improvements in primary outcome measures of balance, and secondary outcomes of gait, physical performance, Unified Parkinson's Disease Rating Scale, Falls, muscle strength. |
NCT04536714 | ALL | ADULT, OLDER_ADULT | Major Depressive Disorder | BEHAVIORAL: Pythagorean Self-Awareness Intervention program | Beck Depression Inventory-II, self-report questionnaire, 2 months | The present study explored the effects of the implementation of the Pythagorean Self Awarenes Intervention (PSAI) on patients diagnosed with major depressive disorder. The primary aim was to evaluate the effectiveness of PSAI compared to the usual care provided for adults with major depressive disorder with respect to the reduction of depressive symptoms. Secondary aims of this study included reduction of stress and anxiety, enhancement of healthy lifestyle and improvement of affect, sleep quality and cognitive functions of patients. |
NCT04796896 | ALL | CHILD | SARS-CoV-2 | BIOLOGICAL: mRNA-1273|BIOLOGICAL: Placebo|BIOLOGICAL: mRNA-1273.214 | Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs), Up to Day 156 (7 days after each injection)|Number of Participants with Unsolicited Adverse Events (AEs), Up to Day 177 (28 days after each injection)|Number of Participants with Medically-Attended AEs (MAAEs), Up to Day 514 (1 year after booster dose)|Number of Participants with Serious Adverse Events (SAEs), Up to Day 514 (1 year after booster dose)|Number of Participants with Adverse Events of Special Interest (AESIs), Including Multisystem Inflammatory Syndrome in Children (MIS-C), Myocarditis and/or Pericarditis, Up to Day 514 (1 year after booster dose)|Number of Participants with AEs Leading to Discontinuation From Study Post-Booster Dose Through the Last Day of Study Participation, Day 149 (booster dose Day 1) through the last day of study participation (Day 514)|Number of Participants with Serum Antibody Levels that Meet or Exceed the Threshold of Protection From COVID-19, Threshold of protection as predefined for study., Day 57 (1 month after second injection)|Geometric Mean (GM) Value of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Specific Serum Antibody, Day 57 (1 month after second injection)|Seroresponse Rate of Vaccine Recipients, Day 57 (1 month after second injection)|GM Value of Post-Booster Dose SARS-CoV-2 Specific Serum Antibody, Day 149 (post third dose)|Seroresponse Rate of Post-Booster Dose of Vaccine Recipients, Day 149 (post third dose) | The primary goal for this study is to evaluate up to 3 dose levels of mRNA-1273 vaccine given to healthy children as intramuscular (IM) injection in 2 doses (in Parts 1 and 2) and 3 doses (in Part 3), and a third dose or an optional booster dose (BD) (in Parts 1 and 2). |
NCT00168857 | ALL | ADULT, OLDER_ADULT | Hypertension|Diabetic Nephropathies | DRUG: telmisartan|DRUG: losartan | Change from baseline after one year of treatment in proteinuria (ratio of protein to creatinine as measure in spot urine sample)., Up to 1 year | A number of blood pressure lowering drugs in the class known as angiotensin receptor blockers (ARB) have been shown to slow the decline in kidney function of patients with type 2 diabetes, high blood pressure, and kidney disease. Losartan (COZAAR), is one such drug. The purpose of this research study is to determine if after one year of treatment telmisartan (MICARDIS, GLIOSARTAN, KINZAL, KINZALMONO, PREDXAL, PRITOR, SAMERTAN, TELMISARTAN) 80 mg, another blood pressure lowering drug from the ARB class, is as effective as losartan (COZAAR) 100 mg in reducing the level of urinary protein (indicative of improved kidney function). |
NCT01909713 | ALL | CHILD | Acne Prone Skin | DRUG: Facial Cleanser and Moisturizer SPF 30 | Cutaneous Tolerability Based on Visual Inspection - Erythema, Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Erythema: 0 = none, no observable redness; 1 = very mild, slight redness, spotty or diffuse; 2 = mild, moderate redness; 3 = moderate, intense; 4 = severe, fiery red with edema., Week 3|Cutaneous Tolerability Based on Visual Inspection - Edema, Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Edema: 0 = none; 1 = mild; 2 = moderate; 3 = intense., Week 3|Cutaneous Tolerability Based on Visual Inspection - Dryness, Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Dryness: 0 = no observable scaling; 1 = fine flakes/scaling; 2 = moderate flakes/scaling; 3 = larger flakes/severe scaling., Week 3|Cutaneous Tolerability Based on Visual Inspection - Roughness, Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Roughness: 1 - no roughness, skin is fine, silky smooth, 2 - firm (not too rough, not too smooth), 3 - coarse, rough skin, 4 - leathery, flaky skin., Week 3 | The purpose of this study is to determine the tolerability of Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30 in pediatric subjects (7-11) with acne prone skin. |
NCT00520182 | ALL | ADULT, OLDER_ADULT | Diabetes Type 2 | BEHAVIORAL: MUFA diet|BEHAVIORAL: ADA 2003|BEHAVIORAL: Low Glycemic index (LGI) diet | Triglyceride level, glycated hemoglobin level, fasting plasma glucose, baseline and every 3 months during year 1, every 6 months therafter | Obese patients with type 2 diabetes often fail to loose weight and thus do not succeed in improving their sugar and lipid profiles and remain at high risk for diabetes complications
The study enrolled 259 obese diabetic patients attending HMO clinics in central Israel. Over a 6 month period the participants met with a dietitian every fortnight and attended group lectures every 2 months.
The objective of this intervention was to compare three dietary intervention along with close monitoring of the patients by dietitians, regarding blood lipid and sugar balance as well as weight loss. The three diets are the American Diabetes Association (ADA) diet from 2003; a diet containing low glycemic index carbohydrate otherwise similar to the ADA diet; and a low glycemic index diet with more fat than the other 2 diets with high proportion of mono-unsaturated fatty acids.
Patients were individually randomized to receive one of the three diets. Among the measures obtained every 3 months for the first year and every 6 months thereafter are weight, fasting insulin and glucose, glycosylated hemoglobin, blood and urine chemistry profiles and lipid profile. |
NCT03725605 | ALL | ADULT, OLDER_ADULT | Soft Tissue Sarcoma | COMBINATION_PRODUCT: LTX-315 and TILs | Change in Total T-cell Level in Tumour Tissues From Baseline (Step 1, Week 1, Day 1) to End of Step 1 (Step 1, Week 3-5), The total T-cell level was measured at baseline and end of Step 1. Change from baseline was listed as absolute change. Data cannot be presented on subject-level and are therefore presented as the arithmetic mean value for the factor increase (+) or decrease (-) in number of cells/mm2 from baseline to end of Step 1., 15 to 42 days|Adverse Events (AE) Related to LTX-315 or to the Combination of LTX-315 and Adoptive T-cell Therapy From Baseline (Step 1, Week 1, Day 1) to End of Treatment (EoT) (Step 2, Week 7), AEs were events occurring during or after administration of the IMP. AEs were coded using MedDRA version 21.1 and were classified by System Organ Class (SOC), Preferred Term (PT) and Lowest Level Term (LLT).
Adverse events related to LTX-315 were events where causality to LTX-315 was marked on the adverse events page.
Adverse events related to the combination of LTX-315 and adoptive T-cell therapy were events where both causality to LTX-315 and at least one of the other IMPs (TILs, Sendoxan®, Fludara® and Proleukin®) were marked on the adverse event page., Up to 133 days | ATLAS-IT-04 is a two part, single arm study designed to determine the safety and effectiveness of LTX-315 to induce T-cell infiltration prior to TIL expansion in patients with soft tissue sarcoma. Following intratumoural injection of LTX-315 to a selected lesion, the lesion will be extracted for T-cell culture, expansion and infusion. |
NCT02866747 | ALL | ADULT, OLDER_ADULT | Glioblastoma | RADIATION: Hypofractionated stereotactic radiation therapy|DRUG: Durvalumab | Phase I: Dose Limiting Toxicities (DLT) incidence, For each patient of the phase I part, DLT incidence will be evaluated until one month after the last radiotherapy fraction., 8 months|Phase II: overall survival, 36 months post randomization | This study is a phase I/II, national, multicenter, open-label study starting with a Phase I part followed by a Phase II part.
The phase I part of the study aims to evaluate the safety of the association of hypofractionated stereotactic radiation therapy (hFSRT) and the anti-PD-L1 Durvalumab immunotherapy in patients with recurrent glioblastoma. A maximum number of 12 patients will be enrolled in this phase I part.
Once the recommended combination schema will be declared, patients will be enrolled in the Phase II part of the study in order to evaluate the efficacy (overall survival) of the combined treatment in recurrent glioblastoma. In this Phase II part, 100 patients will be assigned by randomization to one of the two following arms:
* Arm A (control arm): Radiation therapy alone
* Arm B (Experimental arm): Combined treatment with Anti-PD-L1 Durvalumab |
NCT02428634 | ALL | CHILD | Cardiovascular Disease | BEHAVIORAL: PSIE13|BEHAVIORAL: PSIE46 | Difference between control and intervention groups in the mean change in questionnaire's scoring from baseline to 3-year and 6-year intervention for children., To evaluate children's lifestyle we use a specific questionnaire about knowledge, attitudes and habits in relation to the four components of Program SI! for Elementary (diet, physical activity, body and heart, and emotions management) (article under revision). A trained team of psychologist applies the children's questionnaires at the school., 3-year, and 6-year changes from baseline of questionnaire scoring for children|Cardiovascular health markers (blood pressure, height, weight, waist circumference and triceps and subscapular skinfold thickness) of children from baseline to 3-year and 6-year intervention., To evaluate the impact of the Program SI! for Elementary in cardiovascular health markers of children blood pressure and some anthropometric parameters are measured (height, weight, waist circumference and triceps and subscapular skinfold thickness) under standardized protocol developed in previous studies (Santos-Beneit et al. 2014)., 3-year, and 6-year changes from baseline on cardiovascular health markers of children | The objective of the study is to evaluate the effects of Program SI! for Elementary in different times of exposure for childrens and their immediate environment (teachers and parents). For this purpose, 48 public schools from the Community of Madrid-South Area (Spain) were randomly assigned to Program SI! during 3 or 6 academic years (intervention group) or keep their normal curriculum (control group). The main outcome is 3-year, and 6-year changes from baseline of questionnaire scoring of children, their parents and teachers in regards to a healthy lifestyle. For children were included 3-year, and 6-year changes of cardiovascular markers derived from blood pressure and anthropometry. |
NCT01789177 | ALL | ADULT, OLDER_ADULT | Postoperative Complications | DEVICE: Incentive Spirometry|OTHER: Postoperative chest physiotherapy | Return to baseline or predicted pulmonary function, Return to baseline/predicted pulmonary function based on peak expiratory flow measurement. Postoperative measurement will be compared to preoperative measurement (for elective cases) or age-predicted measurement (for emergency cases), postoperative course up to discharge | We hypothesize that the addition of modified incentive spirometry to standard postoperative chest physiotherapy will be associated with faster return to baseline/predicted pulmonary function and fewer postoperative pulmonary complications in patients following laparotomy. |
NCT02152150 | ALL | CHILD | Iron Deficiency and Anemia | OTHER: Iron bio-fortified pearl millet|OTHER: Control pearl millet | Change in iron status, Hemoglobin, serum ferritin, serum transferrin receptor, body iron, 6 months | The objective of this study was to evaluate the efficacy of iron bio-fortified pearl millet in improving iron status in adolescents in India. |
NCT02923349 | ALL | ADULT, OLDER_ADULT | Advanced Malignancies|Metastatic Cancer | DRUG: INCAGN01949 | Number of Participants With Treatment-related Adverse Events, Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment, From screening through 60 days after end of treatment, up to 11 months | The purpose of this study is to determine the safety and tolerability and assess preliminary efficacy of INCAGN01949 in subjects with advanced or metastatic solid tumors. |
NCT03031951 | ALL | ADULT, OLDER_ADULT | Obesity | BEHAVIORAL: Lifestyle Intervention Group | Whole body fat mass (FM), To estimate total FM, dual energy X-ray absorptiometry (Hologic Explorer-W, Waltham, USA) will be used. A whole-body scan will be performed and the attenuation of X-rays pulsed between 70 and 140 kV synchronously with the line frequency for each pixel of the scanned image will be measured.
Total abdominal FM by identifying a specific region of interest (ROI) within the analysis programme., 12 month|Abdominal Fat Mass, Specific DXA ROIs for abdominal regional fat will be defined as follows: ROI 1, the upper edge of the second lumbar vertebra (approximately 10 cm above the L4 to L5) to above the iliac crest and laterally encompasses the entire breadth of the abdomen, thus determining total abdominal fat mass., 12 months | Given the lack of support for lifestyle management in post-career and considering the high rates of physical inactivity and overweight in former elite athletes, the aim of this research project is to analyze the efficacy and effectiveness of a lifestyle intervention in former athletes. |
NCT03344146 | ALL | ADULT, OLDER_ADULT | Adherence, Patient|Stroke, Ischemic | BEHAVIORAL: Medication intake reminders|BEHAVIORAL: Pillbox use and counselling | Change of non-optimal timing adherence to DOACs, Non-optimal timing adherence is defined as at least one DOAC dose not recorded or recorded outside of 25% of the prescribed dosing time schedule, 0 - 3 months, 3 - 6 months, 6 - 9 months | Primary objective of the MAAESTRO trial is to evaluate the impact of an educational and reminder-based intervention on the adherence of stroke patients to DOACs. Secondary objectives are to evaluate the association between non-adherence and clinical events, to identify predictors of non-adherence and to compare objective measures of adherence with self-reporting.
Key methodological instrument for this study will be the "Time4Med" pillbox with Smart/ Reminder Card. The study includes 3 visits (baseline visit 0, follow-up visit 1 and end-of-study visit 2) with a total follow-up of 9 months.
After an initial 3-month observational phase with electronic monitoring of adherence using the "Smart Card", all patients will receive counselling based on their electronically recorded drug intake data, as well as a multicompartment pillbox. Patients will be then randomised to one of two groups in a crossover design, so that in the subsequent 6-month interventional phase one group will use a (reminder-delivering) "Reminder Card" for the first 3 months and the "Smart Card" for the last 3 months, while the second group will use the cards in reverse order. |
NCT00709891 | FEMALE | ADULT, OLDER_ADULT | Human Papilloma Virus (HPV) | DEVICE: cobas® 4800 HPV Test | Percentage of Participants With a Diagnosis of ≥ CIN2, A diagnosis of ≥ CIN2 (cervical intraepithelial neoplasia) included histology results of CIN2, CIN3, adenocarcinoma in situ, squamous cell carcinoma, or adenocarcinoma. The diagnosis was based on central pathology review., Baseline to the end of the Baseline period (up to 12 weeks) | This study provided data on the performance of the Cobas® 4800 HPV Test for identifying histologically confirmed high-grade cervical disease. The baseline, cross-sectional phase was conducted in approximately 45,000 women undergoing routine cervical cancer screening, of whom approximately 7,400 were selected to undergo colposcopy and biopsy/endocervical curettage (ECC) at baseline. These subjects included women with cytology that is 'not normal' and a selection of those with 'normal' cytology who entered a follow-up phase and underwent cytological evaluation annually for 3 years. In this follow-up phase, colposcopy and biopsy/ECC were performed only in women with cervical cytology considered 'not normal' at any of the annual follow-up visits. |
NCT01321944 | ALL | ADULT, OLDER_ADULT | Tobacco Dependence | OTHER: Direct to Smoker Outreach Program | proportion of participants who reported using any tobacco dependence treatment during the 3-month study period, Tobacco dependence treatment is defined as (1) any smoking cessation counseling contact (with the Tobacco Treatment Coordinator, the Massachusetts Smokers Quitline, or in-person counseling) or (2) any FDA-approved smoking cessation pharmacotherapy (nicotine patch, gum, lozenge, inhaler, or nasal spray; bupropion; or varenicline)., 3 months | Tobacco use is the leading preventable cause of death in the United States. Effective treatment for tobacco dependence exists and includes counseling and pharmacotherapy with nicotine replacement, bupropion, or varenicline. The health care system is a key channel for delivering this treatment to smokers. Brief clinical interventions delivered at office visits increase smoking cessation rates, are among the most cost-effective of medical interventions, and are recommended by U.S. Public Health Service. However, physicians and other clinicians often fail to provide them. Clinicians' rates of providing tobacco treatment in ambulatory care can be improved, but even when successful, clinicians can only reach smokers who make an office visit.
A health care system might improve its delivery of tobacco treatment by supplementing visit-based efforts with a population-based strategy, using methods proven effective in public health settings. A population of smokers could be identified from electronic health records and offered treatment proactively in a way that maximizes convenience and minimizes barriers such the cost of pharmacotherapy. This study tests the effectiveness of a population-based Direct-to-Smoker (DTS) outreach program provided to smokers in one community health center in Revere, MA, that is part of an integrated health care system. It uses the system's population management tools to identify smokers and proactively offers them evidence-based tobacco treatment that is free and does require making an office visit. A randomized controlled trial will compare the effectiveness of the DTS program to usual primary care. The hypothesis is that adding the DTS program to usual primary care will increase the proportion of smokers who use tobacco dependence treatment and thereby stop smoking. |
NCT01526265 | ALL | ADULT, OLDER_ADULT | Tobacco Use Disorder | BEHAVIORAL: Usual Care|BEHAVIORAL: Individual Rewards|BEHAVIORAL: Fixed Deposits|BEHAVIORAL: Competitive Deposits (Pari-Mutuel)|BEHAVIORAL: Collaborative Rewards | Salivary cotinine or anabasine testing (metabolites of nicotine), The primary measure of smoking cessation will be prolonged abstinence for 6 months, which will be measured by salivary cotinine testing or by urinary anabasine testing (for those participants using nicotine replacement therapy). Saliva samples will be analyzed using semi-quantitative immunochromatographic assay test strips at the University of Pennsylvania. Urine samples will be analyzed using gas chromatography at the Associated Regional and University Pathologists (ARUP) Lab, at the University of Utah., at 6 months following the patient selected target quit date. | Using the NIH-funded Way to Health platform, the investigators will conduct this smoking cessation randomized controlled trial (RCT) among CVS employees. The investigators will be able to determine the comparative and absolute efficacy and effectiveness of 4 different incentive structures that are each grounded in behavioral economic principles. Additionally, the investigators will measure rates of and reasons for acceptance of each incentive structure, and examine participant characteristics that modify the efficacy and acceptance of different incentive structures. |
NCT01532063 | ALL | ADULT, OLDER_ADULT | Difficult Intubation | PROCEDURE: INTUBATION IN INTENSIVE CARE UNIT | Difficult intubation, According to ASA criteria, difficult intubation is measured by attempts lasting more than 10 min or more than two attempts, until to 10 minutes | Difficult intubation is challenging in intensive care units. There are limited data regarding risk factors of difficult intubation in ICU. The primary purpose of the investigators study is to assess the risk factors of difficult airway in adults in ICU. |
NCT01044290 | ALL | ADULT, OLDER_ADULT | Cancer|Congestive Heart Failure (CHF)|Chronic Obstructive Pulmonary Disease (COPD)|End Stage Renal Disease (ESRD) | OTHER: Life Completion|OTHER: Attention Control | QUAL-E - Preparation Sub-scale, Quality Of Life At The End Of Life (the QUAL-E 2009) is a 31 item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. We include the 4-item preparation sub-scale as a primary outcomes measure. Individual items used a 5 point likert scale. The sub-scale minimum score was 5 and maximum was 20 with higher numbers indicating higher preparation., Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 56, 64)|QUAL-E Life Completion Sub-scale, Quality Of Life At The End Of Life (the QUAL-E 2009) is a 31 item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. We include the 7-item life completion sub-scale as a primary outcomes measure. Individual items used a 5 point likert scale. The sub-scale minimum score was 7 and maximum was 35 with higher scores indicating greater completion., Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 55, 64) | The purpose of this study is to determine whether discussions of life story, forgiveness, and future goals improve quality of life for patients with serious illness. |
NCT03831048 | ALL | ADULT, OLDER_ADULT | Heart Transplant | DEVICE: OCS Heart System|OTHER: Cold Storage | Survival, Patient survival 6 months post-transplant, 6 months | To evaluate the effectiveness of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation. |
NCT00692211 | ALL | ADULT, OLDER_ADULT | Colorectal Neoplasms | OTHER: Mailed fecal occult blood tests|OTHER: Mailed fecal immunochemical tests | Colorectal Cancer Screening, Completing fecal blood test within 90 days of enrolling, 3 months | We will evaluate if we can increase colorectal cancer screening rates by directly sending screening tests to patients rather than waiting for them to come to clinic visits. We are also evaluating a new test--fecal immunochemical tests--which does not require patients to make dietary or medication changes. We will see if patients are more likely to complete these tests than the standard fecal occult blood tests. |
NCT01989754 | ALL | ADULT, OLDER_ADULT | Diabetes Mellitus, Type 2|Albuminuria | DRUG: Placebo|DRUG: Canagliflozin, 100 mg|DRUG: Canagliflozin, 300 mg | Progression of Albuminuria, Progression defined as the development of micro-albuminuria (Urine Albumin Creatinine Ratio \[UACR\] 30 to 300 milligram per gram \[mg/g\]) or macroalbuminuria (Albumin/creatinine ratio \[ACR\] of greater than \[\>\] 300 mg/g) in a participant with baseline normoalbuminuria (ACR less than \[\<\] 30 mg/g) or the development of macro-albuminuria in a participant with baseline microalbuminuria with an ACR increase greater than or equal to (\>=) 30 percent from baseline. Participants with macroalbuminuria at baseline (ACR\>300 mg/g) were excluded from the analysis. Event rate was estimated based on the time to the first occurrence of the event., Up to 3 years | The purpose of this study is to assess the effect of canagliflozin compared to placebo on progression of albuminuria in participants with Type 2 Diabetes Mellitus receiving standard care but with inadequate glycemic control and at elevated risk of cardiovascular events. |
NCT00124852 | ALL | OLDER_ADULT | Cognitive Impairment|Depression | BEHAVIORAL: n-3 Fatty Acid Supplementation | Cognitive function|Depression | The efficacy of EPA-DHA supplementation will be assessed in a randomized placebo-controlled trial with cognitive decline and early signs of depression as primary outcome measures. |
NCT01135056 | ALL | ADULT, OLDER_ADULT | Hepatocellular Carcinoma | DEVICE: SIR-Spheres|DRUG: Sorafenib tosylate | Overall Survival, Overall Survival is defined as the time from the date of randomisation to the date of death due to any cause. All patients will be followed up until death to compare the overall survival between the two treatments. 2 years is an estimated time frame., 2 years | The primary objective of this study is to assess the efficacy of SIRT as compared with Sorafenib in patients with locally advanced liver cancer in terms of overall survival (OS).
The Study null hypothesis is, there is no difference in overall survival between patients receiving SIRT and those receiving Sorafenib therapy. |
NCT02179983 | ALL | ADULT, OLDER_ADULT | Bronchiectasis | PROCEDURE: Pulmonary rehabilitation|PROCEDURE: Pulmonary rehabilitation | 6 minute walk distance, 8 weeks post exacerbation | Pulmonary rehabilitation is well established as a treatment in COPD. After exacerbations of COPD, rehabilitation is associated with reduced frequency of exacerbations and improved exercise capacity. No data are available in bronchiectasis.
This study will randomly assign patients with bronchiectasis exacerbations to pulmonary rehabilitation or standard care. The hypothesis is that exercise capacity will be improved by pulmonary rehabilitation at 8 weeks. |
NCT05035212 | ALL | ADULT, OLDER_ADULT | Lower Respiratory Tract Illness | BIOLOGICAL: RSVpreF|BIOLOGICAL: Placebo | Efficacy Study: Number of first episode of RSV-associated lower respiratory tract illness (LRTI-RSV) in the first RSV season, Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. LRTI-RSV is defined as an ARI with 2 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.
Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. LRTI-RSV is defined as an ARI with 3 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset., From Day 15 after vaccination until the end of season 1 visit (an average of 6 months)|Efficacy Study: Proportion of participants reporting prompted local reactions within 7-days after vaccination, Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: \> 5.0 to 10.0 cm and severe: \>10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity, Within 7 days after vaccination|Efficacy Study: Proportion of participants reporting prompted systemic events within 7-days after vaccination, Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (\>=)38.0 degrees (deg) Celsius (C), mild (\>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C), moderate (\>38.9 to 40.0 deg C and \>40.0 deg C), severe (\>38.9 deg C to 40.0 deg C) and grade 4 (\>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: \>2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h., Within 7 days after vaccination|Efficacy Study: Proportion of participants reporting AE within 1-month after vaccination, An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events., Within 1 month after vaccination (up to 35 days)|Efficacy Study: Proportion of participants reporting SAE throughout the study, SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly., Throughout the study duration (an average of 30 months)|Efficacy Study: Proportion of participants reporting NDCMC throughout the study, An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects (eg, asthma)., Throughout the study duration (an average of 30 months)|SSA: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 2-dose of RSVpreF, RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Titers (GMTs), and geometric mean fold rise (GMFR). The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum., Before revaccination and 1, 6, 12 and 18-months after revaccination with RSVpreF in SSA|SSA: Proportion of participants reporting prompted local reactions within 7-days after revaccination, Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: \> 5.0 to 10.0 cm and severe: \>10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity, Within 7 days after revaccination|SSA: Proportion of participants reporting prompted systemic events within 7-days after revaccination, Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (\>=)38.0 degrees (deg) Celsius (C), mild (\>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C), moderate (\>38.9 to 40.0 deg C and \>40.0 deg C), severe (\>38.9 deg C to 40.0 deg C) and grade 4 (\>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: \>2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h., Within 7 days after revaccination|SSA: Proportion of participants reporting AE within 1-month after revaccination, An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events., Within 1 month after revaccination (up to 35 days)|SSA: Proportion of participants reporting SAE throughout the study, SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly., Throughout the study duration (approximately 18 months)|SSA: Proportion of participants reporting NDCMC throughout the study, An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects (eg, asthma)., Throughout the study duration (approximately 18 months)|SSB: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 2-dose of RSVpreF, RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Titers (GMTs), and geometric mean fold rise (GMFR). The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum., Before revaccination and 1, 6, 12 and 18-months after revaccination with RSVpreF in SSB|SSB: Proportion of participants reporting prompted local reactions within 7-days after revaccination, Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: \> 5.0 to 10.0 cm and severe: \>10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity., Within 7 days after revaccination|SSB: Proportion of participants reporting prompted systemic events within 7-days after revaccination, Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (\>=)38.0 degrees (deg) Celsius (C), mild (\>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C), moderate (\>38.9 to 40.0 deg C and \>40.0 deg C), severe (\>38.9 deg C to 40.0 deg C) and grade 4 (\>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: \>2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h., SSB: Proportion of participants reporting prompted systemic events within 7-days after revaccination|SSB: Proportion of participants reporting AE within 1-month after revaccination, An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events., Within 1 month after revaccination (up to 35 days)|SSB: Proportion of participants reporting SAE throughout the study, SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly., Throughout the study duration (approximately 18 months)|SSB: Proportion of participants reporting NDCMC throughout the study, An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects (eg, asthma)., Throughout the study duration (approximately 18 months) | Efficacy Study: This randomized, double-blinded, placebo-controlled Phase 3 study is designed to assess the safety, immunogenicity, and efficacy of a single dose of RSVpreF in the prevention of LRTI-RSV in adults:
* At a dose of 120µg.
* In adults 60 years of age and older.
* The duration of the study for each participant will be up to approximately 24 months.
* The study will be conducted in the United States, Canada, Netherlands, Finland, Argentina, Japan and South Africa.
Substudy A: This study is an extension of the efficacy study and was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 2 years:
* At a dose of 120µg (as studied in the Phase 3 Efficacy Study)
* Blood samples will be collected for antibody testing.
* The duration of the study for each participant will be up to approximately 18 months.
* The study will be conducted in the United States and Argentina.
Substudy B: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 1 year:
* At a dose of 120µg (as studied in the Phase 3 Efficacy Study)
* Blood samples will be collected for antibody testing.
* The duration of the study for each participant will be up to approximately 18 months.
* The study will be conducted in Argentina. |
NCT00313157 | ALL | ADULT, OLDER_ADULT | Atrial Fibrillation | DRUG: Metoprolol|DRUG: Diltiazem|DRUG: Verapamil|DRUG: Carvedilol | Ventricular rate, Ventricular rate evaluated after three weeks on study drug treatment, Three weeks | The purpose of this study is to compare the effect of metoprolol, verapamil, diltiazem and carvedilol on ventricular rate, working capacity and quality of life in patients with chronic atrial fibrillation. |
NCT01377857 | ALL | CHILD, ADULT | HIV | BEHAVIORAL: Monetary Incentive|BEHAVIORAL: Questionnaire Timing|BEHAVIORAL: HIV Test Offering | Proportion of patients offered an HIV test who accept, Monthly | Over twenty percent of HIV-positive persons in the United States are unaware of their infection, leading the Institute of Medicine to recently urge further work to compare the effectiveness of HIV screening strategies. This study will use a randomized trial to compare several variants of emergency-room-based HIV-testing policies in order to determine how HIV test acceptance rates can be increased. The testing policies will be designed using principles from behavioral economics, varying the choice architecture and offering small monetary incentives. This will be the first study to measure differences in take-up rates across a variety of promising but largely untested approaches within a unified randomized trial. Three defaults will be tested: traditional opt-in (test only those patients who request testing), opt-out (routinely testing unless patients decline), and active-choice testing (patients are required to state whether they want to be tested). The study will also be the first to test the effect of small monetary incentives ($1, $5, $10) on test take-up. An additional novel study contribution will be to test the hypothesis that compliance with large requests (accept an HIV test) increases after making a small request or pre-commitment - this "foot in the door" technique has not been previously studied in this setting. The factorial design will permit a direct comparison of all interventions, as well as interactions. The study will contribute a nuanced empirical understanding of how testing protocols from behavioral economics theory affect the effectiveness and efficiency of screening programs in an actual scaled- up setting (San Francisco General Hospital). This will assist in implementing and assessing recent CDC guidelines on HIV screening, while also more generally advancing scientific knowledge related to applying behavioral economics in comparative effectiveness research. |
NCT05902247 | MALE | ADULT, OLDER_ADULT | Prostatic Neoplasms, Castration-Resistant | RADIATION: Radionuclide Therapy | Incidence and severity of Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0, Safety and tolerability assessment, 4 years|Absolute values and changes from baseline in laboratory parameters (hematology, blood chemistry and urinalysis), including assessment of shifts from baseline to abnormal values on treatment, Safety and tolerability assessment, 4 years|Absolute values and changes from baseline in vital signs & ECG parameters, Safety and tolerability assessment, 4 years | 225Ac-PSMA I\&T is a radiopharmaceutical for therapy of prostate cancer. PSMA is overexpressed on prostate cancer cells. Actium-225 is an alpha emitting radionuclide. When PSMA I\&T is labelled with Actium-225, it can be applied as therapy for prostate cancer. |
NCT00632853 | ALL | ADULT, OLDER_ADULT | Lung Cancer | RADIATION: Standard Radiation Dose Therapy|DRUG: cisplatin|DRUG: etoposide|RADIATION: High Radiation Dose Therapy|DRUG: carboplatin | Overall Survival Time, Overall survival time is defined as the time between a patient's registration and death or end of survival follow up., 11.25 years | Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as etoposide, carboplatin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which radiation therapy regimen is more effective when given together with chemotherapy in treating patients with limited-stage small cell lung cancer. This randomized phase III trial is comparing different chest radiation therapy regimens to see how well they work in treating patients with limited-stage small cell lung cancer. |
NCT00382863 | ALL | ADULT, OLDER_ADULT | Heart Failure | DEVICE: HeartNet Ventricular Support System|DRUG: Optimal Medical/Device Therapy | Responder Analysis - Peak Oxygen Uptake (Peak VO2), A participant was considered a "responder" if cardiopulmonary exercise testing demonstrated an improvement in peak VO2 of at least 1.0 ml/kg/min at 6 months as compared to baseline., Baseline to 6 months|Responder Analysis - Six (6) Minute Walk (6MW) Distance, A participant was considered a "responder" if 6MW distance at 6 months was at least 45 meters more than at baseline., Baseline to 6 months|Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score, A participant was considered a "responder" if the MLHF overall score had improved by at least 7 points at 6 months as compared to baseline. THE MLHF questionnaire evaluates the impact of heart failure (HF) on a subject's physical, emotional, social and mental aspects of quality of life. Each of 21 questions about how much HF impacts daily activities is scored from 0-no impact to 5-very much (overall score can range from 0 to 105). Improvement is indicated by a decrease in score., baseline to 6 months|Number of Participant Deaths, Total number of participants who died within 12 months of enrollment into the trial., 12 months | The purpose of this study is to determine if patients in the HeartNet Ventricular Support System with optimal medical and device therapy arm (Treatment group) show statistically significant improvement compared to patients in the optimal medical and device therapy alone arm (Control group) after 6 months of follow-up. |
NCT00133523 | ALL | ADULT | Influenza | BIOLOGICAL: Cold-adapted live attenuated influenza virus vaccine, trivalent|OTHER: Placebo|BIOLOGICAL: Trivalent inactivated influenza vaccine|BIOLOGICAL: Trivalent inactivated influenza vaccine|OTHER: Placebo | The appearance among patients of symptomatic laboratory-confirmed influenza., Influenza season Nov-Apr. Within 72 hours of illness onset throat swab specimens will be obtained from participants with influenza like illness (ILI). | The purpose of this study is to compare 2 licensed flu vaccines to each other and to placebo (inactive substance). The study will be conducted among healthy adult participants aged 18-49 years and is expected to last 3 years. During year 1, participants will be assigned to receive 1 of the 2 licensed flu vaccines or placebo, given as either nasal spray (live-attenuated vaccine or placebo) or injection (inactivated vaccine or placebo). Participants will receive the same assigned vaccine or placebo during year 2. During year 3, participants will be followed, but will not receive flu vaccine. Each year blood samples will be collected before and 1 month after each vaccination and at the end of each flu season in order to measure how the body responds to the vaccine and how well participants were protected from the flu. During the flu season, participants with flu-like illness will provide information on symptoms and provide a throat swab to test for virus identification. |
NCT01723280 | ALL | ADULT, OLDER_ADULT | Laparotomy | DRUG: Oxygen | Frequency of patients with the composite outcome measure of either a subsequent, new or recurrent, cancer registration or a new histological specimen showing any neoplasm, 36-60 months after randomization | Aim: to investigate the effect of a high inspiratory oxygen fraction (FiO2) given during and after laparotomy procedures on occurrence of a subsequent, new or recurrent, cancer diagnosis at a long-term follow-up.
Background: A high inspiratory oxygen fraction (FiO2 = 0.80) has been linked to prevention of surgical site infection, but the Danish randomized clinical multicenter trial, the PROXI trial, found no difference in frequency of surgical site infection. In fact, long-term mortality was significantly increased with a hazards ratio of 1.30 in patients receiving 80% oxygen, and this appeared to be statistically significant in patients undergoing cancer surgery, but not in non-cancer patients.
At this point, no convincing mechanism explains the observed increased mortality after hyperoxia, as the long-term pathophysiological effects of oxygen are not fully understood.
Primary hypothesis of this follow-up study of the PROXI trial: Use of 80% oxygen increase the frequency of patients with a subsequent, new or recurrent, cancer. |
NCT00582907 | ALL | CHILD, ADULT, OLDER_ADULT | Familial Mediterranean Fever | DRUG: Rilonacept|DRUG: Placebo | To Assess the Efficacy of Rilonacept in Decreasing the Number of Acute FMF Attacks., Difference in number of attacks per treatment month between rilonacept and placebo, attacks were assessed at the end of each 3 month treatment course (overall up to 6 month of rilonacept and 6 months of placebo, each)|To Determine if There is a Medically Important Difference Between the Safety Profiles of Rilonacept vs. Placebo., Differences in adverse events (AEs) between rilonacept and placebo per patient-month of treatment. We separately analyzed injection site reactions and infectious adverse events. Other adverse events were too small in number to analyze. The upper table (and first statistical analysis) regards injection site reactions and lower table (and second statistical analysis) regards infections., 12 months of entire study length | Familial Mediterranean fever (FMF) is a genetic disease resulting in recurrent attacks of fever, abdominal pain, chest pain, arthritis and rash. There are 5-15% of patients who continue to have FMF attacks despite treatment with colchicine or who cannot tolerate colchicine. Currently there are no alternatives to colchicine. Pyrin, the protein that has a defect in FMF has an important role in the regulation of a molecule called interleukin (IL)-1 beta production and activity. This molecule is very important in the process of inflammation in FMF.
Therefore we propose to use IL-1 Trap (Rilonacept), a medication that binds and neutralizes IL-1.
We will enroll in this study 17 subjects from the age of 4 years, including adults with active FMF despite colchicine therapy. Subjects will receive in random order two 3-month courses of Rilonacept at 2.2 mg/kg (maximum 160 mg) by weekly subcutaneous injection and two 3-month courses of placebo injection. If patients have at least two FMF attacks during a treatment course they will be able to get if they choose the other treatment until the end of that treatment course. Our hypothesis is that Rilonacept will decrease the number of acute FMF attacks and will be safe to use. This study may confirm the importance of IL-1 in the cause of FMF.
Funding source - FDA Office of Orphan Products Development |
NCT01752660 | ALL | ADULT, OLDER_ADULT | Multiple Sclerosis | BEHAVIORAL: Endurance training|BEHAVIORAL: Standard care | Exercise compliance, Compliance to exercise is registered and serve as the primary outcome., Exercise compliance is registered immediatly after all planned exercise sessions during the 4 week intervention|Drop out rate, Number of participants who drop out is registered at the post measurement just after the intervention. | In the last decade physical exercise has become an accepted and integrated part of rehabilitation in patients with multiple sclerosis (MS). However, no studies have evaluated whether the most severely disabled patients can tolerate and benefit from exercise therapy. The purpose of this study is therefore to evaluate the feasibility of endurance training in severely disabled patients with MS. |
NCT01681602 | ALL | ADULT, OLDER_ADULT | Alzheimer Disease | OTHER: Aerobic exercise | Symbol Digit Modalities Test, Change in score from baseline to 16 weeks | Background: Current treatment for Alzheimer's disease (AD) is symptomatic and can only temporarily slow down progression.
Exercise has the potential to improve cognition, psychological symptoms, physical performance and quality of life, but evidence is scarce. Previous trials are short, often underpowered and involving home based light exercise programs. Most have included nursing homes residents with severe or undefined dementia. The aim of the ADEX trial is to establish whether exercise is effective in improving cognition, physical performance and quality of life as well as reducing the prevalence of psychological symptoms among AD patients.
Methods: The ADEX Trial is a multicentre, single-blind, randomized clinical trial. Based on power calculations the investigators plan to recruit 192 home-dwelling patients aged 50-90 years with mild to moderate AD. The participants will be randomly allocated into two groups: An intervention group attending 16 weeks of continuously supervised moderate aerobic exercise 1 hour three times a week and a control group only receiving usual care. The hypothesis is that aerobic exercise will improve physical function, the cognitive and daily functioning and quality of life in people with mild to moderate AS.
Blood sampling will be performed in all subjects to examine effects on biomarkers. A subgroup of the patients will also undergo MRI, PiB-PET and lumbar puncture to investigate structural changes and β-amyloid accumulation.
Further, a health-economic analysis will be performed.
Recruitment was started in January 2012. Last study visits are planned to be performed in January 2014 and results will be available in 2014. This RCT will contribute to evidence regarding the potential effects of a systematic program of physical exercise for patients with Alzheimer's disease. |
NCT00716079 | ALL | ADULT, OLDER_ADULT | Intracerebral Hemorrhage|Stroke|Hypertension | OTHER: Blood pressure management policies | A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS), 90 days | The purpose of this academic lead study is to determine if a treatment strategy of early intensive blood pressure (BP) lowering compared to conservative BP lowering policy in patients with elevated blood pressure within 6 hours of acute intracerebral haemorrhage (ICH) improves the outcome of death and disability at 3 months after onset. |
NCT00404534 | ALL | ADULT, OLDER_ADULT | Functional Dyspepsia | DRUG: Amoxicillin, Clarythromycin, Omeprazole for ten days | Proportion of patients with 50% reduction of baseline symptoms score measured by the validated Porto Alegre Dyspeptic Symptoms Questionnaire, the last visit among the antecipated visits (4, 8 and 12 months) | A double-blind clinical trial investigating if a sub-group of functional dyspeptic patients without any use of NSAID or gastric erosions could have a better evolution of their dyspeptic symptoms after Helicobacter eradication than the placebo control group |
NCT01103687 | ALL | ADULT | HIV Infections | BIOLOGICAL: Ad26.ENVA.01 (rAd26)|BIOLOGICAL: Placebo Vaccine | Local and systemic reactions to vaccine, Measured through the 18-month follow-up visit|Adverse and serious adverse experiences, Measured through the 18-month follow-up visit | The purpose of this study is to evaluate the safety and immune response of an adenovirus-based HIV vaccine in HIV-uninfected adults. |
NCT02818920 | ALL | ADULT, OLDER_ADULT | Non-small Cell Lung Carcinoma | DRUG: Pembrolizumab | Surgical Feasibility Rate as Measured by the Number of Subjects Who Undergo Surgery Following Neoadjuvant Pembrozulimab, A patient who meets the eligibility criteria, has received at least 1 dose of pembrolizumab, and undergone surgery in the window of 29-56 days after initiation of pembrolizumab is considered surgically feasible. All other situations are considered infeasible., 29-56 days after initiation of pembrolizumab | This multi-institutional, phase 2 clinical trial is studying two doses of pembrolizumab administered prior to surgery (neoadjuvant therapy) and 4 doses administered after surgery (adjuvant therapy) for stage IB, II or IIIA non-small cell lung cancer. Pembrolizumab is a type of immunotherapy that may enhance the ability of the immune system to fight off cancer. The study will investigate the effects of pembrolizumab on the immune system and how certain immune cells, called TILs (tumor infiltrating lymphocytes), respond to pembrolizumab. Previous studies suggest that pembrolizumab could alter the immune cells in a way that the the immune cells identify cancer cells. Pembrolizumab has been approved for the treatment of advanced lung cancer, but is investigational in this setting. |
NCT01150448 | ALL | ADULT, OLDER_ADULT | Schizophrenia | DRUG: Paliperidone palmitate Treatment A|DRUG: Paliperidone palmitate Treatment B | The number of patients experiencing treatment emergent adverse events, Screening (Day -21 to -1) to Day 372 (or at the time of early termination from the study)|Concentration of paliperidone in plasma from blood samples obtained from patients, Day 1 to Day 372 | The purpose of this study is to evaluate the long term safety of flexible doses (50 to 150 mg equivalent) of paliperidone palmitate in the treatment of patients with schizophrenia and to document the pharmacokinetics of paliperidone following fixed multiple intramuscular injections of paliperidone palmitate 150 mg eq. |
NCT02773979 | ALL | ADULT | Plasmodium Falciparum Infection | DRUG: Chloroquine|BIOLOGICAL: PfSPZ (NF54) Challenge|OTHER: Placebo | The number of serious adverse events (SAEs) related to study product., Days 1-203|The number of solicited local adverse events (AEs), Days 1-93|The number of solicited systemic adverse events(AEs), Day 1-116|The number of unsolicited adverse events (AEs) related to study product, Days 1-130|The severity of solicited local adverse events (AEs) as assessed by grading scales, Day 1-93|The severity of solicited systemic adverse event (AEs) as assessed by grading scales, Day 1-116|The severity of unsolicited AEs related to study product as assessed by grading scales., Days 1-130 | This phase I trial of the replication-intact PfSPZ Challenge vaccine given under CQ cover will enroll 28 healthy volunteers to receive PfSPZ or placebo, as well as suppressive doses of chloroquine (CQ)on varying schedules. 10 weeks post 3rd immunization subjects will be subjected to controlled human malarial infection. The primary objective of this study is to evaluate the safety and tolerability of escalating doses of Sanaria PfSPZ Challenge administered by DVI on varying schedules to healthy malaria-naïve adults taking suppressive doses of CQ (PfSPZ-CVac). |
NCT00735813 | ALL | CHILD | Bacteremia|Neoplasms | DEVICE: Taurolock|DEVICE: Heparin | Number of catheter related blood stream infections(CRBSI)in the Taurolock group vs the heparin group. Number of CRBSI/1000 CVC days in the Taurolock group vs the heparin group. Number of CVCs removed in the Taurolock group vs the heparin group, November 2010 | Children with cancer need a long term tunnelled central venous catheter (TCVC) for the entire duration of their treatment. TCVCs are locked with heparin when not in use. The most frequent complications of long term TCVC are catheter related blood steam infections. Taurolock is a new lock that is claimed to prevent the formation of luminal biofilm in TCVCs and has been demonstrated to eradicate infected CVCs. In this study the investigators will compare TCVCs locked with heparin with TCVCs locked with Taurolock. Hypothesis: Taurolock will diminish the number of CRBSI in children with cancer compared with children with heparin lock of their CVC. |
NCT02028702 | FEMALE | ADULT, OLDER_ADULT | Menopause|Hot Flushes|Osteoporosis|Dyslipidemia | DIETARY_SUPPLEMENT: Placebo|DIETARY_SUPPLEMENT: Red Clover extract | Primary Menopause-related symptoms, To examine the extent to which red clover extract can reduce the frequency and intensity of hot flashes, sleep disturbances and flush related sweats., 3 months | To investigate the reported health benefits (lipid profile, inflammatory factors, cardiovascular status and bone density) of a novel, phytoestrogen rich, Red Clover treatment on women suffering from both menopause related primary (hot flushes, night sweats, sleep disturbance and weight gain) and secondary (osteoporosis, cardiovascular and changes in lipid metabolism) symptoms. |
NCT03233854 | ALL | ADULT, OLDER_ADULT | B Acute Lymphoblastic Leukemia|CD19 Positive|Minimal Residual Disease|Philadelphia Chromosome Positive | BIOLOGICAL: Chimeric Antigen Receptor T-Cell Therapy|DRUG: Cyclophosphamide|DRUG: Fludarabine Phosphate|OTHER: Laboratory Biomarker Analysis|OTHER: Questionnaire Administration|DRUG: NKTR-255 | Incidence and severity of dose limiting toxicities (DLTs) following chemotherapy preparative regimen and infusion of CD19/CD22 chimeric antigen receptor (CAR) T cells, Safety data will be analyzed per standard methods and interpreted descriptively for each dose cohort. Safety data will be summarized for each dose cohort separately and for all dose cohorts combined. Adverse events will be assessed using the CTCAE version 4.03 for type and severity of event. Serious Adverse Events will be summarized for each dose cohort and for all dose cohorts combined. Reasons for discontinuation of study therapy will be tabulated., Up to 28 days|Maximum tolerated dose of CD19/CD22 chimeric antigen receptor (CAR) T cells defined as the dose level immediately below the level at which the enrollment is stopped due to a dose limiting toxicity, Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03., Up to 28 days|Rate of successful manufacture and expansion of the CD19/CD22 chimeric antigen receptor (CAR) T cells to satisfy the targeted dose level and meet the required release specifications outlined in the Certificate of Analysis, In addition to aiming to evaluate up to 6 subjects at a given dose level with respect to toxicity, the number of subjects which can successfully manufacture the targeted dose number will be determined., Up to 15 years | This phase I trial studies the side effects of CD19/CD22 chimeric antigen receptor (CAR) T cells when given together with chemotherapy and NKTR-255, and to see how well they work in treating patients with CD19 positive B acute lymphoblastic leukemia that has come back or does not respond to treatment. A CAR is a genetically-engineered receptor made so that immune cells (T cells) can attack cancer cells by recognizing and responding to the CD19/CD22 proteins. These proteins are commonly found on diffuse large B-cell lymphoma and B acute lymphoblastic leukemia. Drugs used in chemotherapy, such as cyclophosphamide and fludarabine phosphate, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. NKTR-255 is an investigational IL-15 receptor agonist designed to boost the immune system's natural ability to fight cancer. Giving CD19/CD22-CAR T cells and chemotherapy in combination with NKTR-255 may work better in treating patients with diffuse large B-cell lymphoma or B acute lymphoblastic leukemia. |
NCT03954106 | ALL | ADULT, OLDER_ADULT | DLBCL|Neurotoxicity Syndromes | DRUG: Defibrotide | Incidence of CAR-T-associated Neurotoxicity of Any Grade, Defined by CTCAE v5.0 by CAR-T Day +30, The primary efficacy endpoint was the incidence of CAR-T-associated neurotoxicity of any grade defined by CTCAE v5.0 by CAR-T Day +30. The results report the estimated percentage of participants with no CAR-T-associated neurotoxicity of any grade, defined by CTCAE v5.0, which incorporated the 2 stage design., By CAR-T Day +30 | This is a prospective, open-label, single-arm study evaluating the safety and efficacy of defibrotide for the prevention of CAR-T-associated neurotoxicity in subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) receiving Yescarta. |
NCT03803007 | ALL | ADULT, OLDER_ADULT | Acute Ischemic Stroke | DRUG: Intravenous ACT017 1000 mg|OTHER: Intravenous Placebo | Symptomatic intracranial haemorrhages, Number of participants experiencing a symptomatic haemorrhage defined by a secondary increase in National Institute Health Stroke Scale score by 4 points or greater, or death, 24 hours|Incidence of non-symptomatic intracranial haemorrhages, Non-symptomatic haemorrhages are those detected by Computerized Tomography scan, 24 hours | To assess safety of single IV (bolus + infusion) doses of ACT017 in patients with an acute ischemic stroke in addition to best emergency standard of care (including fibrinolysis by rtPA with or without added thrombectomy), with a specific focus on hemorrhage, whether clinically symptomatic (NIHSS score + 4 points or death, without other explanation), or seen (excluding other diagnoses) on 24-hour (hr) CT scan, serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), and medically important events and other safety items including biological and immunological tolerability. |
NCT02616562 | ALL | CHILD | Growth Hormone Disorder|Growth Hormone Deficiency in Children | DRUG: somapacitan|DRUG: Norditropin® FlexPro® pen | Cohort I: Height velocity (HV) during the first 26 weeks of treatment, measured as standing height with stadiometer, cm/year, Week 0-26|Cohort II and III: Incidence of adverse events, including injection site reactions, in children with GHD, Number of events, During 208 weeks | This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of once-weekly NNC0195-0092 (somapacitan) treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency.
The trial consists of a 26 week main trial period, followed by a 26 week extension trial period, a 104 week safety extension period, a 208 week longterm safety extension trial period and a 30 day follow up period. Participants receive NNC0195-0092 (somapacitan) (0.04 mg/kg/week) during the main trial and the extension period and thereafter NNC0195-0092 (somapacitan) (0.16 mg/kg/week) during the safety extension and the long-term safety extension periods. Two additional age groups, cohort II (age below 2 years and 26 weeks at screening) and cohort III (above 9 years (girls)/ above 10 years (boys) and equal to or below 17 years at screening) are included in the 208 week long-term safety extension trial period only. |